The worldwide market for implant-based dental reconstruction products will approach nearly $3.5 billion by 2010 with an annual growth rate of 15%. Currently, an implant patient waits 3-14 months from the time of tooth extraction until a functioning crown is in place, resulting in significant inconvenience for the patient and high cost for the overall procedure. The goal of this Small Business Technology Transfer Research (STTR) proposal is to develop a novel cemented dental implant system that can eliminate the waiting time and provide broader service for patients. Due to biological and mechanical reasons, the currently available bone cements such as poly(methyl methacrylate) cement and calcium phosphate cement typically used in the cemented orthopedic implants (e.g., hip and knee) are not suitable for jawbone (dental) implants. We have developed a sol gel modified biomimetic hydroxyapatite-gelatin nano- composite, called GEMOSIL, that has great potential to be a bone cement that can permit the immediate loading of dental implants. We expect that GEMOSIL's combination of mechanical properties and capability to be a scaffold for bone growth will allow patients to have a functioning tooth replacement in the same day as tooth extraction. If successful, this will provide the first commercial system for the cemented dental implant. In this Phase I project, we will focus on the development and optimization of GEMOSIL for immediately loaded dental implants. Two specific aims are proposed: 1) Develop a process for putty cement using GEMOSIL biomaterials, and 2) Perform a pilot in vivo test using small animals. The completion of these aims will create new cement and demonstrate that the new cement can be used in vivo. The outcome will position us for the Phase II study to further develop the technology and commercialize the product. The initial market for our product will be as a bone augmentation and anchoring material for dental implants, which will have immediate and significant positive benefits to patients. The addressable market in the US for the dental implant application of GEMOSIL is estimated to be approximately $100M. Other downstream benefits include providing a new tissue engineering biomaterial to replace missing tissues in patients with congenital, developmental or trauma-induced bone deformities. With significant advantages over alternatives, we believe that our product not only can successfully penetrate but also enhance the dental implant market. PUBLIC HEALTH RELEVANCE: Currently, an implant patient needs to wait for 3 -14 months from the time of tooth extraction until he/she has a functioning tooth replacement, resulting in the significant inconvenience for the patient and the high cost of the procedure. The goal of this STTR proposal is to develop a novel GEMOSIL cemented dental implant system that can eliminate the waiting time and provide broader service for disparity patients. We expect that GEMOSIL's combination of mechanical properties and capability to be a scaffold for bone growth will allow patients to have a functioning tooth replacement in the same day as tooth extraction.